Radiological protection - Medical electron accelerators - Requirements and recommendations for shielding design and evaluation (ISO 16645:2016)

ISO 16645:2016 is applicable to medical electron linear accelerators i.e. linear accelerators with nominal energies of the beam ranging from 4 MV to 30 MV, including particular installations such as robotic arm, helical intensity modulated radiotherapy devices and dedicated devices for intra operative radiotherapy (IORT) with electrons.
The cyclotrons and the synchrotrons used for hadrontherapy are not considered.
The radiation protection requirements and recommendations given in ISO 16645:2016 cover the aspects relating to regulations, shielding design goals and other design criteria, role of the manufacturers, of the radiation protection officer or qualified expert and interactions between stakeholders, radiations around a linear accelerator, shielding for conventional and special devices (including shielding materials and transmission values, calculations for various treatment room configurations, duct impact on radiation protection) and the radiological monitoring (measurements).

Strahlenschutz - Medizinische Elektronenbeschleuniger-Anlagen - Anforderungen und Empfehlungen an die Ausführung der Abschirmung und deren Bewertung (ISO 16645:2016, korrigierte Fassung 2016 11)

Diese Internationale Norm gilt für medizinische lineare Elektronenbeschleuniger, d. h. lineare Beschleuniger mit Nennstrahlenergien von 4 MV bis 30 MV einschließlich spezieller Installationen wie robotergestützter Geräte, helikaler fluenzmodulierter Strahlentherapiegeräte und spezieller Geräte für die intraoperative Strahlentherapie (IORT) mit Elektronen.
Für die Hadrontherapie eingesetzte Zyklotrone und Synchrotrone werden nicht berücksichtigt.
Die Strahlenschutzanforderungen und -empfehlungen in dieser Internationalen Norm behandeln die Aspekte in Bezug auf Verordnungen, die Ziele der Abschirmungsgestaltung und anderer Gestaltungskriterien, die Rolle der Hersteller, des Strahlungsschutzbeauftragten oder qualifizierten Experten und die Interaktionen zwischen Stakeholdern, Strahlungen im Umfeld eines linearen Beschleunigers, die Abschirmungen für konventionelle und spezielle Geräte (einschließlich Abschirmungsmaterialien und Übertragungswerte, Berechnungen für verschiedene Behandlungsraumkonfigurationen, die Auswirkung von Kanälen auf den Strahlenschutz) und die radiologische Überwachung (Messungen).
ANMERKUNG 1 Anhang A enthält Übertragungswerte für die häufigsten Abschirmungsmaterialien.
ANMERKUNG 2 Anhang B enthält unterstützende Daten für die Berechnung der Abschirmung.
ANMERKUNG 3 Anhang C enthält ein Beispiel für die Berechnung konventioneller Geräte und eines Standard-Labyrinths.

Radioprotection - Accélérateurs médicaux d'électrons - Exigences et recommandations pour la conception et l'évaluation du blindage (ISO 16645:2016)

L'ISO 16645:2016 s'applique aux accélérateurs linéaires d'électrons médicaux, c'est-à-dire aux accélérateurs linéaires avec des énergies nominales de faisceau dans la gamme de 4 MV à 30 MV, y compris les installations particulières telles que le bras robotisé, les appareils de radiothérapie hélicoïdale avec modulation d'intensité et les appareils dédiés à la radiothérapie peropératoire (IORT) avec électrons.
Les cyclotrons et les synchrotrons utilisés pour l'hadronthérapie ne sont pas considérés.
Les exigences et recommandations en matière de radioprotection données dans l'ISO 16645:2016 couvrent les aspects liés aux réglementations, aux objectifs de conception de la protection radiologique et autres critères de conception, au rôle des fabricants, de la personne compétente en radioprotection ou de l'expert qualifié et aux interactions entre les parties prenantes, aux rayonnements autour d'un accélérateur linéaire, à la protection pour les appareils conventionnels et spéciaux (y compris les matériaux de protection et les valeurs de transmission, les calculs pour différentes configurations de salle de traitement, l'impact des conduits sur la radioprotection) et à la surveillance radiologique (mesurages).
NOTE 1    L'Annexe A procure des valeurs de transmission pour les matériaux de protection les plus courants.
NOTE 2    L'Annexe B fournit des données servant au calcul de la protection radiologique.
NOTE 3    L'Annexe C donne un exemple de calcul pour un appareil conventionnel et une chicane standard.

Radiološka zaščita - Medicinski elektronski pospeševalniki - Zahteve in priporočila za snovanje in ocenjevanje zaščitnih zaslonov (ISO 16645:2016)

Standard ISO 16645:2016 se uporablja za medicinske elektronske linearne pospeševalnike, tj. linearne pospeševalnike z nominalnimi energijami žarka od 4 MV do 30 MV, vključno s posebnimi instalacijami, kot so robotska roka, radioterapevtske naprave, ki so modulirane s spiralno intenziteto, in naprave, namenjene za medoperacijsko radioterapijo (IORT) z elektroni.
Ciklotroni in sinhrotroni, ki se uporabljajo pri hadronski terapiji, niso upoštevani v tem dokumentu.
Zahteve in priporočila za radiološko zaščito, ki so podani v standardu ISO 16645:2016, obravnavajo vidike, povezane s predpisi, cilji snovanja zaščitnih zaslonov in drugih kriterijev snovanja, vlogo izdelovalcev, pooblaščenega izvedenca varstva pred sevanji ali usposobljenega strokovnjaka ter interakcijami med deležniki, sevanjem okoli linearnega pospeševalnika, zaščito za konvencionalne in posebne naprave (vključno z zaščitnimi materiali in vrednostmi transmisije, izračuni za različne konfiguracije ambulant, vpliv cevi na radiološko zaščito) ter nadzorom sevanja (meritve).

General Information

Status
Published
Publication Date
11-Jun-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
12-Jun-2019
Completion Date
12-Jun-2019

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SLOVENSKI STANDARD
SIST EN ISO 16645:2019
01-september-2019

Radiološka zaščita - Medicinski elektronski pospeševalniki - Zahteve in priporočila

za snovanje in ocenjevanje zaščitnih zaslonov (ISO 16645:2016)
Radiological protection - Medical electron accelerators - Requirements and
recommendations for shielding design and evaluation (ISO 16645:2016)

Strahlenschutz - Medizinische Elektronenbeschleuniger-Anlagen - Anforderungen und

Empfehlungen an die Ausführung der Abschirmung und deren Bewertung (ISO
16645:2016)

Radioprotection - Accélérateurs médicaux d'électrons - Exigences et recommandations

pour la conception et l'évaluation du blindage (ISO 16645:2016)
Ta slovenski standard je istoveten z: EN ISO 16645:2019
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN ISO 16645:2019 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16645:2019
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SIST EN ISO 16645:2019
EN ISO 16645
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2019
EUROPÄISCHE NORM
ICS 13.280
English Version
Radiological protection - Medical electron accelerators -
Requirements and recommendations for shielding design
and evaluation (ISO 16645:2016)

Radioprotection - Accélérateurs médicaux d'électrons - Strahlenschutz - Medizinische

Exigences et recommandations pour la conception et Elektronenbeschleuniger-Anlagen - Anforderungen

l'évaluation du blindage (ISO 16645:2016) und Empfehlungen an die Ausführung der
Abschirmung und deren Bewertung (ISO 16645:2016)
This European Standard was approved by CEN on 8 March 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16645:2019 E

worldwide for CEN national Members.
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SIST EN ISO 16645:2019
EN ISO 16645:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 16645:2019
EN ISO 16645:2019 (E)
European foreword

The text of ISO 16645:2016 has been prepared by Technical Committee ISO/TC 85 "Nuclear energy,

nuclear technologies, and radiological protection” of the International Organization for Standardization

(ISO) and has been taken over as EN ISO 16645:2019 by Technical Committee CEN/TC 430 “Nuclear

energy, nuclear technologies, and radiological protection” the secretariat of which is held by AFNOR.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by December 2019, and conflicting national standards

shall be withdrawn at the latest by December 2019.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 16645:2016 has been approved by CEN as EN ISO 16645:2019 without any modification.

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SIST EN ISO 16645:2019
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SIST EN ISO 16645:2019
INTERNATIONAL ISO
STANDARD 16645
First edition
2016-10-01
Corrected version
2016-11-15
Radiological protection — Medical
electron accelerators — Requirements
and recommendations for shielding
design and evaluation
Radioprotection — Accélérateurs médicaux d’électrons — Exigences
et recommandations pour la conception et l’évaluation du blindage
Reference number
ISO 16645:2016(E)
ISO 2016
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SIST EN ISO 16645:2019
ISO 16645:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 16645:2019
ISO 16645:2016(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

3.1 Quantities .................................................................................................................................................................................................... 1

3.2 Definitions ................................................................................................................................................................................................... 4

4 Shielding design goals and other design criteria ............................................................................................................... 6

4.1 Shielding design goals....................................................................................................................................................................... 6

4.2 Shielding design assumptions ................................................................................................................................................... 7

5 Role of the manufacturers, of the radiation protection officer or qualified expert

and interactions between stakeholders ....................................................................................................................................... 8

5.1 General ........................................................................................................................................................................................................... 8

5.2 Linear accelerator manufacturer ............................................................................................................................................ 8

5.3 Shielding material vendor ............................................................................................................................................................. 9

5.4 Architectural firm/general contractor ............................................................................................................................10

5.5 Radiation protection officer or qualified expert .....................................................................................................10

5.6 The licensee ............................................................................................................................................................................................11

6 Radiation fields around a linear electron accelerator ...............................................................................................11

6.1 General ........................................................................................................................................................................................................11

6.2 X-ray radiation ......................................................................................................................................................................................11

6.2.1 Primary X-ray beam ...................................................................................................................................................11

6.2.2 Primary electron beam bremsstrahlung ..................................................................................................12

6.2.3 Secondary X-ray radiation ....................................................................................................................................12

6.2.4 Tertiary X-ray radiation...........................................................................................................................................13

6.3 Neutron radiation ..............................................................................................................................................................................13

6.3.1 General...................................................................................................................................................................................13

6.3.2 Direct neutron radiation ........................................................................................................................................14

6.3.3 Scattered and thermal neutron radiation................................................................................................14

6.3.4 Primary barrier neutron radiation ................................................................................................................15

6.4 γ radiation ................................................................................................................................................................................................15

6.4.1 General...................................................................................................................................................................................15

6.4.2 Maze γ radiation ...................................................................... ......................................................................................15

6.4.3 Door γ radiation.............................................................................................................................................................15

6.4.4 Primary barrier γ radiation .................................................................................................................................15

6.4.5 Air γ radiation .................................................................................................................................................................16

7 Shielding materials and transmission values .....................................................................................................................16

8 General formalism for shielding calculation .......................................................................................................................18

9 Shielding calculation for conventional devices .................................................................................................................20

9.1 General ........................................................................................................................................................................................................20

9.2 Primary barriers .................................................................................................................................................................................20

9.2.1 Radiation components .............................................................................................................................................20

9.2.2 Barrier with a unique material .........................................................................................................................21

9.2.3 Barrier with multiple layers .................. ..............................................................................................................21

9.3 Secondary barriers ...........................................................................................................................................................................22

9.3.1 Radiation components .............................................................................................................................................22

9.3.2 Barrier with a unique material .........................................................................................................................23

9.3.3 Barriers with multiple layers .............................................................................................................................24

10 Doors and mazes ...............................................................................................................................................................................................24

10.1 General ........................................................................................................................................................................................................24

© ISO 2016 – All rights reserved iii
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SIST EN ISO 16645:2019
ISO 16645:2016(E)

10.2 Radiation components ..................................................................................................................................................................25

10.3 Standard maze ......................................................................................................................................................................................25

10.3.1 Maze X-ray scatter calculations ........................................................................................................................25

10.3.2 X-ray direct Leakage .................. ......................................................................................................................... ........30

10.3.3 Maze neutron and capture gamma calculations ................................................................................31

10.4 Two legged maze ................................................................................................................................................................................33

10.5 No maze - Direct-shielded doors ..........................................................................................................................................34

10.5.1 General...................................................................................................................................................................................34

10.5.2 Shielding at the far side of a direct-shielded door entrance ...................................................35

10.5.3 Shielding at the near side of a direct-shielded door entrance ...............................................37

10.6 No door at maze entrance ..........................................................................................................................................................39

10.7 Door Calculations ...............................................................................................................................................................................40

10.7.1 General...................................................................................................................................................................................40

10.7.2 Maze door calculations ............................................................................................................................................40

10.7.3 Direct Shielded Door Calculations .................................................................................................................41

11 Shielding calculations for special devices ...............................................................................................................................41

11.1 General ........................................................................................................................................................................................................41

11.2 Robotic arm accelerator ...............................................................................................................................................................41

11.3 Helical intensity modulated radiotherapy ...................................................................................................................42

11.4 Dedicated device for intra operative radiotherapy with electrons .........................................................42

12 Ducts ...............................................................................................................................................................................................................................43

12.1 Duct impact on radiation protection .................................................................................................................................43

12.2 Recommended location and geometry ...........................................................................................................................43

12.3 Additional shielding ........................................................................................................................................................................44

12.3.1 General...................................................................................................................................................................................44

12.3.2 Neutron and capture gamma radiation passing through the interior of the

shielded duct ....................................................................................................................................................................44

12.3.3 X scattered radiation passing through the interior of the shielded duct .....................45

12.3.4 Scattered radiation passing through the walls of the duct shielding ..............................46

12.3.5 Dose equivalent at HVAC duct exterior opening ................................................................................46

13 Special considerations .................................................................................................................................................................................46

13.1 Skyshine .....................................................................................................................................................................................................46

13.1.1 General...................................................................................................................................................................................46

13.1.2 X-ray skyshine radiation .........................................................................................................................................46

13.1.3 Neutron skyshine radiation .................................................................................................................................48

13.2 Groundshine radiations ................................................................................................................................................................49

13.3 Joints and junctions .........................................................................................................................................................................49

14 Shielding evaluation (experimental verification) ..........................................................................................................49

14.1 General ........................................................................................................................................................................................................49

14.2 Measuring equipment and methodology ......................................................................................................................50

14.3 Evaluation .................................................................................................................................................................................................50

15 Indication, warning signs, interlocks ...........................................................................................................................................52

Annex A (informative) Tenth value layers for the most common shielding materials ..................................53

Annex B (informative) Supporting data for shielding calculations ...................................................................................66

Annex C (informative) Example of calculation for conventional device and standard maze ..................68

Bibliography .............................................................................................................................................................................................................................75

iv © ISO 2016 – All rights reserved
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SIST EN ISO 16645:2019
ISO 16645:2016(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received. www.iso.org/patents

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO’s adherence to the WTO principles in the Technical

Barriers to Trade (TBT), see the following URL: Foreword - Supplementary information

The committee responsible for this document is ISO/TC 85, Nuclear energy, nuclear technologies, and

radiological protection, Subcommittee SC 2, Radiological protection.

This corrected version of ISO 16645:2016 incorporates the correction of Tables A.9 and C.6.

© ISO 2016 – All rights reserved v
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SIST EN ISO 16645:2019
ISO 16645:2016(E)
Introduction

Radiotherapy uses external beam radiation to kill cancer cells and shrink tumours. The use of electron

linear accelerators to administer external beam radiation has spread during recent decades and is now

common throughout the world. These accelerators deliver high energy electron and photon beams with

increasingly high dose rates. Although the use of radiotherapy is well established, irradiation techniques

have continued to evolve and are becoming increasingly complex. Examples include modulation of beam

intensity, availability of high dose rate modes, arctherapy, helical intensity modulated radiotherapy,

robotic arm accelerators, and dedicated devices for intra-operative radiotherapy. The shielding design

of treatment rooms has been evolving with these changes. The higher radiation workload associated

with most of these techniques can impact the shielding materials used. The irradiation technique can

also impact the geometry to be considered in the shielding calculations.

IEC 60601-2-1 relates to the design and the construction of the accelerators in order to ensure the

[1] [2][3]

safety of their operation . In addition, several national or international (IAEA Safety Reports

Series Report No. 47, 2006) reports propose recommendations concerning the installation and the

exploitation of these accelerators, the safety devices, the design and the calculation of protections, the

[4]

radiological control and monitoring. National standards have been established in certain countries

[5]

. Moreover national regulations impose particular rules of protection against radiation, in particular

relating to the definition of the controlled areas and the calculation of shielding.

Taking into account the developments of new irradiation techniques and of new designs of treatment

room facilities on the one hand, and the variety of guides or normative documents on the other hand,

it appeared judicious to establish an international standard to be used as a general framework. This

standard is intended to be complementary to the other international standards (IEC and IAEA).

The following items are discussed in the standard:

— types of accelerators: conventional accelerators with and without flattening filter (FF and FFF

operating modes), devices for helical intensity modulated radiotherapy and robotic arm accelerator,

dedicated machines for intra-operative radiotherapy;

— radiation fields: electrons, X photons and neutrons (direct, scattered, leakage), neutron capture

gamma rays;
— Treatment room geometry: maze without and with door, no maze with direct door;

— materials of protection: concrete (ordinary or high density), metals, laminated barriers (concrete

and metal), hydrogenated materials, earth and others;
— design of the radiotherapy facility:

— calculation methods of the shielding, including neutrons, various types of installations and shielding

geometries;

— evaluation of the impact of the maze and calculation of the protection of the entrance door;

— evaluation of the impact of the ducts (ventilation and air-conditioning, high voltage and fluids) and

additional protections;
— shielding design assumption and goals;

— Radiation survey of the completed installation to ensure national requirements have been met and

the shielding and design is fit for purpose after installation of the accelerator.

vi © ISO 2016 – All rights reserved
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SIST EN ISO 16645:2019
INTERNATIONAL STANDARD ISO 16645:2016(E)
Radiological protection — Medical electron accelerators —
Requirements and recommendations for shielding design
and evaluation
1 Scope
This International Standard is applicabl
...

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